April 16 (Bloomberg) -- Takeda Pharmaceutical Co., Asia’s
biggest drugmaker, denied its Actos drug caused a California
man’s bladder cancer in the first of more than 3,000 lawsuits
over the diabetes medication to go to trial.

Plaintiff Jack Cooper developed bladder cancer, the fifth-most common form of cancer, as a result of factors other taking
Actos, Sara Gourley, a Takeda lawyer, told a state court jury in
Los Angeles today. Cooper, 79, is diabetic and a former smoker,
she said.

“The evidence is not only clear, it is overwhelming, that
Mr. Cooper is in the highest-risk groups, and that his bladder
cancer had nothing to do with Actos,” Gourley said.

Jurors ended deliberations today over whether Takeda, based
in Osaka, Japan, should be held liable for failing to properly
warn patients and their doctors that Actos could cause bladder
cancer. The panel will continue considering the case tomorrow.

Michael Miller, a lawyer for Cooper, told jurors yesterday
that Takeda hid the cancer risks of Actos to protect billions of
dollars in sales. While Takeda’s internal studies uncovered
links to bladder cancer as early as 2004, the company didn’t
alert U.S. regulators until seven years later, he said.

“Selling diabetes drugs is big business in America,”
Miller said in his closing arguments. “There’s a lot of money
to be made. But companies are not allowed to downplay the risk.
Patient safety is the No. 1 thing.”

Actos Sales

In January, Takeda won U.S. regulatory approval for Nesina,
a diabetes drug to replace Actos, which lost patent protection
last year. Actos sales peaked in the year ended March 2011 at
$4.5 billion, or 27 percent of the Takeda’s revenue at the time,
according to data compiled by Bloomberg.

Takeda is facing more than 3,000 suits alleging Actos
caused bladder cancer or other ailments, according to court
records. Cooper’s suit is among those gathered before Judge
Kenneth Freeman in Los Angeles. Other cases are in state court
in Illinois.

More than 1,200 suits have been consolidated before a
federal judge in Louisiana for pretrial information exchanges.
The first federal case is set for trial in January, according to
court filings.

Cooper, a former Pacific Bell Telephone Co. cable splicer
who took Actos for more than two years, was diagnosed with
bladder cancer in November 2011 and “is gravely ill,”
according to Freeman, who put the case on an expedited basis
because of Cooper’s condition.

Executive E-Mails

During the almost two-month trial, Miller produced internal
Takeda e-mails in which executives urged colleagues to persuade
the U.S. Food and Drug Administration not to demand increased
warnings about bladder cancer on Actos’s label.

“Actos is the most important product for Takeda and
therefore we need to manage this issue very carefully and
successfully not to cause any damage for this product
globally,” Takeda executive Kiyoshi Kitazawa said in an e-mail.

Even after FDA officials asked the drugmaker in 2005 and
2006 to update warnings about Actos’s health risks, Takeda
executives “stalled and delayed” because the company “was
making $1.6 billion a year” on the drug, Miller said.

Under U.S. law, it was Takeda’s responsibility to fully
disclose its products’ risks, Miller told jurors.

‘It’s Fair’

“It’s the company’s responsibility and it’s fair,” Miller
said. “The FDA is not making $1.6 billion a year on this drug.
The FDA doesn’t have 800 sales representatives” talking about
the medication with doctors, he said.

In their defense, Takeda officials have said the FDA found
Actos to be safe and effective and they contend there’s no proof
the drug causes bladder cancer.

Gourley said today that although some studies found a
possible “association” of Actos and bladder cancer, none have
uncovered a causal connection. FDA researchers have “not
concluded that Actos increases the risk of bladder cancer,” she
said.

While Cooper’s lawyers told jurors their client had stopped
smoking in the mid-1970s, that wouldn’t take the former
telephone-company employee out of the high-risk category for
getting bladder cancer, Gourley said.

“By 1974, he had smoked at least 21 years,” she said.
“It doesn’t matter when he stopped. The damage was done.”

The Takeda attorney also argued that the company fully
disclosed Actos’s health risks on warning labels, including
information about cancer tumors that appeared in rats being
studied during the drug’s development.